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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Plasma Bottles with Saline Adapter
HAEMONETICS CORPORATION
0694S-00
In Commercial Distribution

  • 30812747011673 ()
  • 00812747011672 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set
Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0699S-12
In Commercial Distribution

  • 00812747019807 ()
  • 30812747019808 ()


  • Apheresis system tubing set
3-NCC987 SCD Wafer
TERUMO BCT, INC.
3NCC987
In Commercial Distribution

  • 55020583260318 ()
  • 35020583260314 ()
  • 05020583260313 ()


  • Package sealing unit
3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
3M COMPANY
24110
In Commercial Distribution

  • 50608223241108 ()
  • 00608223241103 ()
24110

  • Conduction blood/fluid warmer set
3M™ Ranger™ Hose Cap, 12 per Case, 90026
3M COMPANY
90026
In Commercial Distribution

  • 50707387781922 ()
  • 00707387781927 ()
90026

  • Conduction blood/fluid warmer set
HemoCue Plasma/Low Hb Photometer mg/dL
Hemocue AB
120314
In Commercial Distribution

  • 07311091203144 ()
120314

  • Haemoglobin analyser IVD, point-of-care
For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
FENWAL, INC.
4R5730
Not in Commercial Distribution

  • 00811137012916 ()
  • 10811137012913 ()
4R5730

  • Apheresis system tubing set
LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path
FENWAL, INC.
4C4300
Not in Commercial Distribution

  • 10811137010483 ()
  • 00811137010486 ()
  • 0FE04C4300 ()
4C4300

  • Blood transfusion set, non-exchange
SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path
FENWAL, INC.
4C2300
Not in Commercial Distribution

  • 10811137010469 ()
  • 00811137010462 ()
  • 0FE04C2300 ()
4C2300

  • Blood transfusion set, non-exchange
Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path
FENWAL, INC.
4C4502
In Commercial Distribution

  • 10811137010438 ()
  • 00811137010431 ()
4C4502

  • Blood transfusion set, non-exchange
For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5700
In Commercial Distribution

  • 00811137010134 ()
  • 10811137010131 ()
4R5700

  • Apheresis system tubing set
Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database
FENWAL, INC.
2.2
In Commercial Distribution

  • 00811137013050 ()
5S9804

  • Blood bank information system application software
  • Medical equipment clinical data interfacing software
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile Fluid Path.
FENWAL, INC.
4R5742
In Commercial Distribution

  • 00811137012992 ()
  • 10811137012999 ()
4R5742

  • Apheresis system tubing set
Blood separation tube for PRFM
Factor Medical, Inc.
0364
In Commercial Distribution

  • 00851802007120 ()

  • Total Volume: 10 Milliliter
0364

  • Haematological concentrate system preparation kit, platelet concentration
Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0697S-00
In Commercial Distribution

  • 30812747019228 ()

  • Total Volume: 1200 Milliliter


  • Apheresis system tubing set
No Description
Microgenics Corporation
963600
In Commercial Distribution

  • 00884883005945 ()


  • PCR/NAT negative control IVD
No Description
Microgenics Corporation
963601
In Commercial Distribution

  • 00884883005921 ()


  • Hepatitis C virus antibody/antigen IVD, control
No Description
Microgenics Corporation
960600
Not in Commercial Distribution

  • 00884883005907 ()


  • West Nile virus nucleic acid IVD, control
No Description
Microgenics Corporation
963602
In Commercial Distribution

  • 00884883005891 ()


  • HIV1 nucleic acid IVD, control
SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard
DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard
MultiPlasma Sets
TERUMO BCT, INC.
80700
Not in Commercial Distribution

  • 05020583807006 ()
  • 35020583807007 ()


  • Blood transfer set
Disposable Tubing Sets
TERUMO BCT, INC.
80340
Not in Commercial Distribution

  • 05020583803404 ()
  • 35020583803405 ()


  • Blood transfer set
Lipoaspirate Wash System
Sientra, Inc.
Viality-1400
In Commercial Distribution

  • 00810076894621 ()
Viality-1400

  • Autologous adipose tissue noninvasive processing set
Laparoscopic Dual Flexible Applicator
Ethicon Inc.
VSTL45
In Commercial Distribution

  • 30705031462728 ()
  • 10705031462724 ()
  • 20705031462721 ()
VSTL45

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Laparoscopic Dual Rigid Applicator
Ethicon Inc.
VSTL35
In Commercial Distribution

  • 20705031462578 ()
  • 10705031462571 ()
  • 30705031462575 ()
VSTL35

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Rigid, Airless Spray Accessory
Ethicon Inc.
3922S
Not in Commercial Distribution

  • 20705031240466 ()
  • 10705031240469 ()
  • 30705031240463 ()
3922S

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Evicel Airless Spray Accessory
Ethicon Inc.
3921S
Not in Commercial Distribution

  • 20705031230139 ()
  • 10705031230132 ()
  • 30705031230136 ()
3921S

  • Haematological concentrate/haemostatic agent applicator cannula, open-surgery
No Description
BSL Co.,Ltd
ACPU-100
In Commercial Distribution

  • 08800080260026 ()
  • 08800080260019 ()


  • Autologous adipose tissue reinjection set
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